DFWRegistry: Multi-Parametric MRI Assessment of the Liver in the Dallas-FortWorth Metroplex Population

• Sponsor: Perspectum (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04336618
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 27.9
• Patients Per Site Per Month: 3.6

Study Details

Study Description

Brief Summary

To build a Registry of volunteers by inviting them to get a LiverMultiScan(LMS)and collecting their contact information to seek interest in participating in future studies.

Condition or Disease	Intervention/Treatment	Phase
Non-Alcoholic Fatty Liver Disease	Device: Liver MultiScan

Detailed Description

This is a Registry where there will be no intervention to the standard of care.Participants will be required to attend a single visit that will involve having a multi-parametric MRI at no cost to them. In addition, the invesigators will collect contact information of participants including their email address, phone number and house address so that they can be contacted to discuss possible participation in future studies which may be sponsored by Perspectum or third parties, such as pharmaceutical companies, the participants personal information shall never be shared with these third-parties. Additionally, the contact information of the participants medical providers shall be collected so that, if requested, their LMS reports can be used in their diagnostic pathway.

Imaging will be performed at two Touchstone Imaging locations, one in downtown Dallas and the other in Southlake.

A total of 100 participants will be enrolled over a period of 1 year.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Multi-Parametric MRI Assessment of the Liver in the Dallas-FortWorth Metroplex Population
• Actual Study Start Date: Aug 3, 2020
• Anticipated Primary Completion Date: Nov 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Outcome Measures

Primary Outcome Measures

1. To build a Registry of volunteers by inviting them to get a LiverMultiScan(LMS)and collecting their contact information to seek their interest in participating in future studies [12 months]

Secondary Outcome Measures

1. To use multi-parametric MRI (LMS) of the liver to assess the volunteer's liver health [12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Male or female volunteers aged 18 years and over•

• Participant willing and able to give informed consent for participation in the registry.

Exclusion Criteria:

• The participant may not enter the Registry if they have any contraindication to magnetic resonance imaging (standard MR exclusion criteria at the imaging center including pregnancy, extensive tattoos, pacemaker, shrapnel injury, severe claustrophobia).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Perspectum Inc.	Dallas	Texas	United States	75201

Sponsors and Collaborators

• Perspectum

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Perspectum
• ClinicalTrials.gov Identifier: NCT04336618
• Other Study ID Numbers: EC-236
• First Posted: Apr 7, 2020
• Last Update Posted: Apr 25, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease

Study Results

No Results Posted as of Apr 25, 2022